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FDA approves Narcan for over-the-count sales

The U.S. Food and Drug Administration (FDA) has approved the leading version of naloxone, known as Narcan, for over-the-counter (OTC) sales, paving the way for the drug to become the first opioid treatment sold without a prescription. Naloxone is a nasal spray that can reverse opioid overdoses, including those from street drugs such as heroin and fentanyl, as well as prescription opioids such as oxycodone. The drug is widely distributed to police and other first responders across the United States, and the FDA’s decision to make it available OTC is seen as a critical strategy to control the nationwide overdose crisis, which has been linked to over 100,000 U.S. deaths annually.


The nonprofit Harm Reduction Therapeutics Inc. has an application before the FDA to distribute its version of naloxone without a prescription. Other brands of naloxone and injectable forms will also be required to file applications to switch their drugs OTC as part of an FDA requirement.

Before the FDA’s decision, naloxone was available in pharmacies without a prescription in every U.S. state, but it was not carried by every pharmacy. The drug was also distributed by community organizations, but it was not easily accessible to everyone who needed it, and buyers had to pay for it, either with insurance co-pay or the full retail price, which could be around $50 for two doses of Narcan.


While the move to make naloxone available OTC will help improve access, it is not clear how many stores will carry it or at what price. Moreover, one concern is whether people who buy Narcan OTC will know how to use it properly. Keith Humphreys, a Stanford University addiction expert, believes that one benefit of having pharmacists involved in the distribution of naloxone is that they can show buyers how to use it. One key reminder for people is to call an ambulance for the person receiving naloxone after it has been administered.

The FDA approval of OTC sales for Narcan is seen as a positive move by many advocates. Chuck Ingoglia of the National Council for Mental Wellbeing said that the decision “represents a decisive, practical and humane approach to help people and flatten the curve of overdose deaths.”